A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Pancreatic Cancer
Both
Metastatic Pancreatic Cancer
Trial Information
A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
- Metastatic disease
- Documented disease progression after prior gemcitabine based therapy
- KPS >/= 70
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
Exclusion Criteria:
- Active CNS metastasis
- Clinically significant GI disorders
- Severe arterial thromboembolic events less than 6 months before inclusion
- NYHA Class III or IV congestive heart failure, ventricular arrhythmias or
uncontrolled blood pressure
- Active infection or uncontrolled fever
- Pregnant or breast feeding patients
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
24 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
MM-398-07-03-01
NCT ID:
NCT01494506
Start Date:
November 2011
Completion Date:
June 2014
Related Keywords:
- Metastatic Pancreatic Cancer
- Pancreatic cancer
- MM-398
- PEP02
- Metastatic pancreatic cancer
- Gemcitabine refractory pancreatic cancer
- Second line pancreatic cancer treatment
- Pancreatic cancer post gemcitabine therapy
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Albany, Georgia 31701 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| McLean, Virginia 22101 | |
| Albuquerque, New Mexico 87131-5636 | |
| Charleston, South Carolina | |
| Tulsa, Oklahoma | |
| Las Vegas, Nevada 89109 |
